Evidence-based Patient Information Research Articles

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)\u2014study protocol for a randomised controlled trial

IntroductionMultiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis.MethodsThe pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle.DiscussionWe hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management.Trial registrationClinicalTrials.govNCT04233970. Registered on 18 January 2020

Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)

IntroductionMultiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis...

Impact of a multimedia website with patient experiences of multiple sclerosis (PExMS) on immunotherapy decision-making: study protocol for a pilot randomised controlled trial in a mixed-methods design

BackgroundA variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis (RRMS). Besides coping with the diagnosis, people with MS (pwMS) have to make complex decisions such as deciding about immunotherapies. In addition to factual information, reports of patient experiences (PEx) may support patients in decision-making. The added value of PEx in decision-making is not clear, and controlled studies are rare. Therefore, systematic methods are necessary to develop and analyse PEx. As there are no evaluated PEx for MS in Germany, we are currently creating a website presenting PEx structured according to topics and illustrated by video, audio, and text files. We aim to determine the feasibility of an intervention using PEx and evaluate whether PEx may help pwMS in their immunotherapy decision-making processes as a supplement to evidence-based information.MethodsThis project will follow the Medical Research Council framework for development and evaluation of complex interventions. After the development of a website with PEx, a randomised controlled pilot trial (pilot RCT) will be conducted in 2–3 MS centres, clinics, or rehabilitation centres including 55 pwMS and accompanied by a process evaluation. Patients with a RRMS diagnosis considering immunotherapy are eligible. The primary outcome is decision self-efficacy. Secondary outcomes include preparation for decision-making, decisional conflict, risk knowledge, confidence in active participation, affective forecasting, social support, and self-reported impact of eHealth on its users. Participants will be randomly assigned either to (i) an intervention group with 4 weeks access to an evidence-based patient information resource and the PExMS-website as an adjunct or to (ii) the control group with access to evidence-based information alone. A 6-member advisory panel involving representatives of pwMS, researchers, and neurologists, who accompany the whole project, will mentor this pilot RCT.DiscussionThe intervention was developed with systematic methods, created with active patient involvement and in critical appraisal by an expert advisory panel. The study is innovative as it contributes to the controversial evidence on the use of PEx in the context of evidence-based patient information.Trial registrationClinicalTrials.gov, NCT04236544

A longitudinal study to investigate the effects of a 12-week comprehensive lifestyle weight management program on body weight and quality of life

The majority of Americans now have overweight or obesity. With limited resources to treat all patients, group programs are emerging as an efficient method for dissemination of evidence-based lifestyle information. The objective of this study was to evaluate change in body weight, biochemical parameters, and quality of life among individuals after completion of a 12-week comprehensive group weight management program at an obesity medicine clinic. 204 patients were recruited for the study after enrolling in the Healthy Habits for Life program at the Massachusetts General Hospital Weight Center in Boston and Danvers, MA. Prior to the program, patients met individually with a dietitian and baseline data was collected. Primary outcome measures collected were weight and BMI change over the course of the program. Secondary measures collected included biochemical parameters and quality of life. Weekly group visits consisted of primary outcome collection and 1.5h of instruction on various lifestyle- and nutrition-related topics. Secondary outcome measures were reassessed at an individual visit with the dietitian after the program concluded. 142 participants were adherent to the protocol (attended 9 out of 12 classes). On average, patients lost 6.4kg (14.1 lbs.), representing a percent total body weight loss of over 5%. Average BMI decrease was significant at 5.35±4.61%. Improvements were seen in physical function, self-esteem, and sexual life; total QOL scores also improved by a significant 5.79% on average. There were also significant improvements in total cholesterol, triglycerides, and HbA1c. The Healthy Habits for Life group program was an effective treatment for obesity and related health concerns, including overall quality of life. Group programs of this style may be a more efficient was to disseminate evidence-based lifestyle information and affect change for patients with overweight or obesity.

32.K. Skills building seminar: Using participatory health research to optimise psycho-oncological patient information material

Abstract Patient information material (PIM) is omnipresent in healthcare. It is used to convey information or to familiarize potential end-users to offers of support. PIM recaps or elaborates on relevant information and offers recommendation for action. However, the quality of available PIM varies. When the formal and content-related quality of PIM is suboptimal, it not only fails to be effective but can also lead to uncertainty, misunderstandings, resistance or ignorance (e.g. of a support offer). Highly complex information requires much attention on the quality of the PIM, especially with respect to end-users (e.g. vulnerable groups). Excellent communication through the use of PIM is thus essential within complex interventions. Checklists, such as 'Discern' or 'PEMAT', as well as criteria catalogues or evidence-based patient information standards, may assist in the development, quality assessment and optimization of PIM. The inclusion of the end-users is recommended but for various reasons does not often take place. The innovative “integrated, cross-sectional Psycho-Oncology” (isPO) programme, offers needs-driven, professional support to all adult, newly diagnosed cancer patients early in their sickness trajectory. IsPO was developed in 2018. It was implemented and a formative evaluated in 2019. When developing this programme, different PIM were created top-down by the programme designers. During implementation, it became evident that these PIM materials required further improvement. A testing and optimization process started using the participatory health research (PHR) approach and was completed in a five-month period. A PIM-optimisation team was founded, which included the project partners involved in the network support, self-help organisations and the external evaluation institute. A practical instrument (PIM-checklist) for optimising the isPO-PIM was designed, piloted and used for testing by end-users, isPO service providers, and experts. Based on the recommendations in the checklist, the material was revised accordingly. Additionally, the PIM was completed with the design of two new components. Four optimisation rounds were conducted. The optimized PIM was tested on its comprehensibility (for end-users) and its usability (for service providers). During the presentations, the audience is invited to comment on critical questions that may appear during optimization (e.g. timing). Afterwards, there will be a skill building part with a focus on collaborative learning (45 minutes). First, we will focus on the requirements for a practical instrument that is handy for end-users, service providers and experts (mind mapping exercise). Finally, participants will be able to explore the following topics “World Café” discussion: (1) how to plan, conduct and communicate the development of optimization of PIM in a CI program, (2) what needs to be considered for the optimization (e.g. team composition, resources), and (3) how to continuously achieve end-userś participation. Key messages Excellent PIM are essential for a complex interventiońs success in practice and must include information and foster actionability. the iterative PIM design processes benefits from high user participation.

Predicting 10-Year Risk of End-Organ Complications of Type 2 Diabetes With and Without Metabolic Surgery: A Machine Learning Approach.

To construct and internally validate prediction models to estimate the risk of long-term end-organ complications and mortality in patients with type 2 diabetes and obesity that can be used to inform treatment decisions for patients and practitioners who are considering metabolic surgery. A total of 2,287 patients with type 2 diabetes who underwent metabolic surgery between 1998 and 2017 in the Cleveland Clinic Health System were propensity-matched 1:5 to 11,435 nonsurgical patients with BMI ≥30 kg/m2 and type 2 diabetes who received usual care with follow-up through December 2018. Multivariable time-to-event regression and random forest machine learning models were built and internally validated using fivefold cross-validation to predict the 10-year risk for four outcomes of interest. The prediction models were programmed to construct user-friendly web-based and smartphone applications of Individualized Diabetes Complications (IDC) Risk Scores for clinical use. The prediction tools demonstrated the following discrimination ability based on the area under the receiver operating characteristic curve (1 = perfect discrimination and 0.5 = chance) at 10 years in the surgical and nonsurgical groups, respectively: all-cause mortality (0.79 and 0.81), coronary artery events (0.66 and 0.67), heart failure (0.73 and 0.75), and nephropathy (0.73 and 0.76). When a patient's data are entered into the IDC application, it estimates the individualized 10-year morbidity and mortality risks with and without undergoing metabolic surgery. The IDC Risk Scores can provide personalized evidence-based risk information for patients with type 2 diabetes and obesity about future cardiovascular outcomes and mortality with and without metabolic surgery based on their current status of obesity, diabetes, and related cardiometabolic conditions.

Communicating prognosis to women with early breast cancer \u2013 overview of prediction tools and the development and pilot testing of a decision aid

BackgroundShared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example.MethodsSystematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups.ResultsWe identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported.Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions.ConclusionsNone of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids.

Nurse-led coaching of shared decision-making for women with ductal carcinoma in situ in breast care centers: A cluster randomized controlled trial

BackgroundWomen with breast cancer demand informed shared decision-making. Guidelines support these claims. ObjectivesTo investigate whether an informed shared decision-making intervention for women with ‘ductal carcinoma in situ’ comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual shared decision-making behavior of patients and professionals regarding treatment options, and to analyze implementation barriers. DesignCluster randomized controlled trial with accompanying process evaluation. SettingCertified breast care centers in Germany. ParticipantsWomen with ductal carcinoma in situ and no previous history of breast cancer facing a primary treatment decision. MethodsSixteen breast centers were randomized to intervention or standard care to recruit 192 patients (partially-blinded). All coaching sessions and physician consultations were videotaped to assess the primary outcome ‘extent of patient involvement in shared decision-making’ using the MAPPIN-Odyad observer instrument (scores 0 to 4). Secondary endpoints included the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), ‘informed choice’, ‘decisional conflict’ and ‘duration of consultations’. Primary intention-to-treat analyses were on cluster level comparing means of cluster values using t-tests. An accompanying process evaluation was conducted comprising 1) analysis of all video recordings with focus on procedures and intervention fidelity and 2) field notes of researchers and feedback from professionals and patients assessed by questionnaires and interviews with focus on barriers and facilitators for implementation at different time points. ResultsDue to protracted recruitment, the study was terminated after 14 centers had included 64 patients (intervention group 36, control group 28). Patient participation in informed shared decision-making was significantly higher in the intervention group (mean (SD) score 2.29 (0.56) vs. 0.42 (0.51) in the control group; difference 1.88 (95% CI 1.26–2.50, p < 0.0001). 47.7% women in the intervention group made informed choices, but none in the control group, difference 47.7% (95% CI 12.6–82.7%, p = 0.016). In the intervention group physician consultations lasted 12.8 (6.6) min. vs. 24.3 (6.3) min. in the control group. Physicians’ attitudes, false incentives and structural barriers hindered implementation of informed shared decision-making. Nurses appreciated their new roles. ConclusionsInformed shared decision-making is not yet implemented in German breast care centers. Nurse-led decision coaching grounded on evidence-based patient information enhances informed shared decision-making.Trial registration No. ISRCTN46305518.

Efficacy of Group Evidence-Based Food Safety Education for Hematopoietic Cell Transplant (HCT) Patients

Topic Significance & Study Purpose/Background/Rationale There are no nationally standardized methods by which pre-HCT recipients and caregivers receive food safety education. HCT patients are at increased risk for foodborne illness. Seattle Cancer Care Alliance Registered Dietitian Nutritionists developed a 1-hour food safety class, which patients and caregivers are scheduled to attend pre-HCT. Methods, Intervention, & Analysis We conducted a survey of HCT recipients designed to assess attendance, perceived usefulness and compliance with Food Safety/Immunosuppressed Diet instruction provided in a weekly food safety class. At discharge, patients were asked to complete the 47-question survey and return in a sealed privacy envelope. Findings & Interpretation A total of 110/111 HCT recipients completed the survey (53% allogeneic, 47% autologous). Respondents had a median age of 57 yrs (range 25-75) and the majority received a myeloablative (90/105 [86%]) transplant. The majority (99/109 [91%]) attended the food safety class; most with their caregiver (93/109 [85%]). Respondents found the class either very informative (71/90 [79%]) or moderately informative (19 [21%]). Despite education, the most frequently non-recommended foods consumed by patients were raw nuts (n=16), uncooked deli/lunchmeat (14) and soft/blue cheeses (10). Discussion & Implications A weekly food safety class is a time-efficient way to share evidence-based diet information for HCT patients and caregivers. The majority of HCT recipients and their caregivers attended and found the class informative. Follow-up with a RDN remains crucial to ensure comprehension of guidelines for high-risk foods and address cultural/individual preferences. For patients unable to attend the class due to hospitalization or infection, we developed an educational video, which may help guide education at other transplant centers. Having standardized education opportunities provided by RDNs for all pre-HCT patients ensures consistent dissemination of information, which minimizes the burden of food safety education required from nursing and other intradisciplinary providers.

PP28 Adoption Of Non-Pharmaceuticals In Galicia: Beyond Conventional Health Technology Assessment

IntroductionThe specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.MethodsIn depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.ResultsA multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).ConclusionsRigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.

Psycho-social impact of developmental dysplasia of the hip and of differential access to early diagnosis and treatment: A narrative study of young adults.

Objectives:Symptomatic developmental dysplasia of the hip can present in the young, active adult patient and can lead to severe pain and disability at a young age. The overall aim of the study was to deepen the understanding of the impact of developmental dysplasia of the hip on young adults’ quality of life and psycho-social well-being, focusing on how differential access to early diagnosis impacted the trajectory of the disease and treatment options.Methods:We conducted semi-structured interviews and gathered online stories from 97 participants. A narrative and thematic analysis was used to integrate the dataset producing a multi-dimensional view.Results:A narrative plot showing how events unfolded over time was identified for each participant. Two common plots were identified: Plot 1 focused around those participants who received a prompt diagnosis and were treated within 12 months of diagnosis (n = 22) and Plot 2 focused around those who experienced a late/delayed diagnosis (mean = 8 years; range = 12–364 months) (n = 75) and thus delayed treatment. Participants in Plot 2 became more debilitated over time and experienced chronic hip pain for a prolonged period before an accurate diagnosis and/or intervention was made. It was clear from the narratives when pain persists over time, participants’ quality of life and psycho-social well-being were affected.Conclusions:Developmental dysplasia of the hip is an under-recognised condition; more research is needed to develop a clear clinical picture that can be used to alert frontline health professionals to the potential for developmental dysplasia of the hip so that they can promptly diagnose patients and refer them to specialist centres. Patients can also experience a profound impact on their quality of life and psycho-social well-being. Patients actively seek information from support groups about all aspects of their condition. Further research is required to determine the long-term impact of developmental dysplasia of the hip to develop evidence-based information for clinicians and patients.

Addison's at high altitude - developing an evidence based patient information resource for Addison's patients who travel to high altitude

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Lingual orthodontics – clinical applications and patient information

The demand for adult orthodontic treatment is an ever-increasing trend that has driven the development of aesthetic orthodontic systems. Lingual orthodontic appliances provide the ultimate in aesthetics and their use has grown with the development of the appliances. The clinical application of different lingual appliances is described and evidence-based patient information is provided. CPD/Clinical Relevance: Increasing demand for aesthetic orthodontic systems means that lingual appliances are, and are likely to become, more popular in the future. A broad knowledge of their clinical application and useful evidence-based information to give to patients is invaluable for all dental practitioners.

Evaluation of patient information leaflets for non-invasive prenatal testing for Down's syndrome

Aims To validate an evidence-based patient information leaflet (PIL) to support women considering non-invasive prenatal testing (NIPT) for Down's syndrome. Methods A PIL was developed based on qualitative interviews and expert review. The PIL was evaluated by women offered NIPT for Down's syndrome as part of a research study. Questionnaires assessed usefulness, relevance, technicality and scope on a four point Likert scale. Qualitative interviews allowed a more in-depth exploration of views on the PIL. Findings The PIL was well received by women. Overall, they found it clear and easy to understand. Some women suggested the word heavy PIL could be enhanced through the addition of pictures, colour and altered line spacing. Conclusions The majority of women found the PIL useful when considering NIPT for Down's syndrome. The validated PIL could inform development of information resources for women during the future introduction of NIPT into the NHS Fetal Anomaly Screening Programme in the UK.

Can facts trump unconditional trust? Evidence-based information halves the influence of physicians' non-evidence-based cancer screening recommendations.

Informed decision making in medicine, defined as basing one’s decision on the best current medical evidence, requires both informed physicians and informed patients. In cancer screening, however, studies document that these prerequisites are not yet met. Many physicians do not know or understand the medical evidence behind screening tests, do not adequately counsel (asymptomatic) people on screening, and make recommendations that conflict with existing guidelines on informed choice. Consistent with this situation, nation-wide studies showed that the general public misperceives the contribution of cancer screening but that understanding considerably improves when evidence-based information is provided. However, can evidence-based patient information about cancer screening make people also less likely to simply follow a physician’s non-evidence-based advice? A national sample of 897 German citizens, surveyed in face-to-face computer-assisted personal interviews, received either evidence-based (e.g., absolute risks on benefits and harms; n = 451) or non-evidence-based (e.g., relative risks on benefits only; n = 446) patient information about a cancer screening test and were then asked to make their initial cancer screening choice. Thereafter, participants received a hypothetical physician’s recommendation, which was non-evidence-based in terms of existing guidelines on informed decision making (i.e., reporting either benefits or harms but not both; no provision of numbers). When provided with non-evidence-based patient information (n = 446), a mean of 33.1% of 235 participants whose initial screening choice contradicted the hypothetical physician's non-evidence-based recommendation adjusted their choice in deference to that recommendation (95% CI: 27.4 to 39.4%), whereas with evidence-based patient information (n = 451), only half as many, a mean of 16.0% of 225 (95% CI: 11.8 to 21.4%), modified their choice. Thus, evidence-based patient information makes people less likely to simply follow non-evidence-based recommendations of physicians and supports people in making evidence-based decisions even when not adequately counseled on cancer screening.

The Quality of Patient Information Booklets for Cancer Patients-an Evaluation of Free Accessible Material in German Language.

According to the information-seeking behaviors of patients, booklets which can be downloaded from the Internet for free are an important source of information notably for patients with cancer. This study investigated whether information booklets for patients with cancer available at German websites are in accordance with the formal and content criteria of evidence-based information. We compared and compiled both content and formal criteria by matching different national and international standards for written patient information using a merged instrument. A catalog with a total of 16 items within 4 categories (quality of the publication, quality of information, quality of information representation, and transparency) was created. Patient information booklets for the most frequent tumor types were collected from the Internet. A total of 52 different patient booklets were downloaded and assessed. Overall, no booklet fulfilled all criteria. The quality of the publications was evaluated with an average value of 1.67 while the quality of the information had a mean value of 1.45, and the quality of information presentation had a similar rating (1.39). The transparency criteria were evaluated as lowest with an average of 1.07. In summary, German booklets for cancer patients have some shortcomings concerning formal and content criteria for evidence-based patient information. The applied requirement catalog is suitable for wide use and may help in quality assurance of health information. It may be used as part of an obligatory external evaluation, which could help improving the quality of health information.

Development of an Online, Evidence-Based Patient Information Portal for Congenital Heart Disease: A Pilot Study.

In response to an increased need for patient information on congenital heart disease in the Netherlands, we initiated a nationwide initiative to develop an online, evidence-based patient information portal, starting with a pilot project aimed at the subgroup of patients with congenital aortic and pulmonary valve disease. We developed an information portal that aims to (1) improve patient knowledge and involvement and to subsequently reduce anxiety and decisional conflict and improve mental quality of life and (2) to support physicians in informing and communicating with their patients. The information portal was developed according to the systematic International Patient Decision Aid Standards development process employing Delphi techniques by a multidisciplinary workgroup of pediatric and adult congenital cardiologists, a congenital cardiothoracic surgeon, a psychologist, an epidemiologist, a patient representative, and web and industrial design experts. First, patients and physicians were surveyed and interviewed to assess the current state of patient information and explore their preferences and needs to determine the focus for the development of the information portal. We found that patient knowledge and numeracy are limited, reliable information is scarce, physicians inform patients selectively and patient involvement is suboptimal, and there is a need for more reliable, tailored, and multi-faceted information. Based on the findings of these surveys and interviews, a patient-tailored information portal was designed that presents evidence-based disease- and age-specific medical and psychosocial information about diagnosis, treatment, prognosis, and impact on daily life in a manner that is comprehensible and digestible for patients and that meets the needs expressed by both patients and physicians. The effect of the website on patient outcome is currently being assessed in a multicenter stepped-wedge implementation trial. The present pilot project succeeded in developing an online, evidence-based information portal that is supported by both patients and physicians. The information portal will be further developed and expanded to include all other major forms of congenital heart disease, translations into other languages, and a public information portal to serve patients' relatives and the general public at large.

Development and Feasibility of an Evidence-Based Patient Education Program for Managing Fatigue in Multiple Sclerosis: The "Fatigue Management in MS" Program (FatiMa).

Multiple sclerosis (MS) is an inflammatory and neurodegenerative disease of the central nervous system. Fatigue is a common and disabling symptom, often causing decreased quality of life, social withdrawal, and unemployment. We developed and studied the feasibility of a cognitive-behavioral group intervention to manage fatigue in MS. We aimed to integrate the concepts of cognitive-behavioral therapy and evidence-based patient information. We conducted patient interviews and a focus group to assess patients' interest in and need for fatigue self-management training and developed the program accordingly. The program consists of six 90-minute modules, which were structured with the use of moderation cards, helping to guarantee treatment fidelity. The program was tested on three pilot groups (N = 16) in a rehabilitation center. Fatigue, depression, and coping self-efficacy were assessed at baseline and after the intervention. Acceptance and general satisfaction with the program were also evaluated. Patient interviews elicited different characteristics of fatigue, suggesting that patients had different requirements. The program was very acceptable to patients. Pre-post assessments of the pilot study showed significantly improved scores on the Coping Self-Efficacy Scale (P = .013) but not on the Fatigue Scale for Motor and Cognitive Functions and the 30-item Inventory of Depressive Symptomatology. These preliminary results suggest that this program is a feasible cognitive-behavioral group training program that may improve coping self-efficacy and has the potential to subsequently reduce fatigue. The next step is evaluation of the program in a randomized controlled trial.

Do Written Interventions Discourage Inappropriate Screening

Reducing use of low-value screening tests (i.e., those that result in net harm or offer only a small possible benefit) requires effective interventions to change patient behavior. In this study, researchers evaluated four different ways to present evidence-based information to patients on risks and benefits of three such screening tests: prostate cancer screening in middle-aged men (age range, 50–69), …

Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial.

BackgroundWomen with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices.In this trial, the informed shared decision-making program will be evaluated in breast care centers.Methods/DesignA cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2 hours) and specialized breast care and oncology nurses (4 days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited.Primary outcome is the extent of patients’ involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the ‘sharing’ in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters.It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients’ involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted.DiscussionTo our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers.Trial registrationCurrent Controlled Trials ISRCTN46305518, date of registration: 5 June 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0991-8) contains supplementary material, which is available to authorized users.